The n e w e ng l a n d j o u r na l of m e dic i n e

Edi t or i a l s

NEJM Evidence — A New Journal in the NEJM Group Family

Chana A. Sacks, M.D., M.P.H., C. Corey Hardin, M.D., Ph.D.,
Sharon‑Lise Normand, Ph.D., M.Sc., Siri Kadire, M.D., Kate Takvorian, M.D., M.P.H.,
Neil Galloway, Rebekah Linga, Patrick Hannon, Jeffrey Drazen, M.D., and Eric Rubin, M.D., Ph.D.

Over the past 20 years, the team at the New
England Journal of Medicine has reviewed many cut-
ting edge or clinically important research manu-
scripts that we did not publish. Some of the
groundbreaking work was just not ready for
prime time: studies that revealed new biologic
insights with the potential to one day change
practice but that lacked findings sufficient to
support immediate clinical utility. Many clini-
cally important research trials posed the oppo-
site problem: prior work had already established
a novel paradigm, so even rigorously conducted
trials expanding that paradigm’s range of utility
were deemed not new enough to merit publica-
tion. This approach made sense and kept the
amount of material published in the weekly
Journal manageable. It had a downside: the Jour-
nal did not publish some transformative work,
such as the use of circulating fetal DNA in a
pregnant person’s blood to diagnose fetal abnor-
malities or the use of interferon gamma release
assays for the diagnosis of tuberculosis. It also
meant that the Journal did not publish the addi-
tional clinical trials that cemented the use of
agents active on the PD-L1 pathway in certain
cancers where its use has since become the stan-
dard of care.
This is about to change. In January 2022, the
NEJM Group will begin publishing a new jour-
nal, NEJM Evidence. This monthly, peer-reviewed,
online-only, general medical journal will publish
original research that takes ideas and turns
them into reality. This research includes work
along the full spectrum of clinical investigation,
from first-in-human demonstrations of safety
and potential efficacy that will pave the way for
larger and longer clinical trials, at one extreme,
to investigations that solidify the evidence and
push a diagnostic or therapeutic into widespread
use at the other.
But NEJM Evidence will go even further. The
editors of NEJM Evidence believe that understand-
ing the nuances of study design and execution is
key to understanding how the results of a study
can, or cannot, influence our clinical practice.
Too often, readers’ eyes glaze over when they hit
the Methods section of a research article; 20 years
ago, when one of us took over as editor-in-chief
at the Journal, the Methods section was even
printed in a smaller font than the rest of the
article. Understanding a trial’s methods, grap-
pling with the choices the investigators confront-
ed when planning the trial, and evaluating the
potential impact of the inevitable trade-offs in-
herent to complex clinical research are critical to
understanding how the data in a research report
can inform the care of your patient, in your com-
munity.
To tackle this challenge head on, NEJM Evi-
dence will bring a new focus to making methods
and trial design engaging. We will publish fo-
cused commentary on how a trial’s methodology
may influence the importance of the observed
outcomes to clinical practice. We will feature
case studies written by investigators sharing, in
depth, the challenges they confronted and the
choices they made during the course of a spe-
cific trial (see our first, titled “Behind the Scenes

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 Editorials

of TOPCAT — Bending to Inform”). We will
develop short educational videos (which we are
calling “Stats, STAT!”) focused on high-yield
statistical methodology relevant to clinicians and
investigators. We will give clinical trial partici-
pants a platform to share their experience, as we
work to intentionally elevate diverse, new voices
and perspectives too often excluded from con-
versations across academic publishing.
Much of our content will be specifically tar-
geted toward clinicians. In addition to classic
review articles, we will publish a number of
novel article types. Our “Morning Report” series
will present short case reports similar to those
experienced by trainees and will be authored by
members of clinical training programs from
around the world. The series is designed to
bring an evidence-based approach to clinical
reasoning. “Tomorrow’s Trial” will invite clini-
cians to share examples of common medical
practices that are not supported by robust evi-
dence and are ripe for a challenge in the form of
a randomized trial. We hope this series will
shine a spotlight on these open clinical ques-
tions, advance the discussion about the barriers
to definitively answering them, and ultimately
spawn research to fill the gaps. Our “Curbside
Consult” series will address clinical quandaries
that physicians face daily on rounds. These short
review articles are meant to provide the best cur-
rent answers to focused questions — short
enough to read quickly, and authoritative enough
to leave the reader comfortable making clinical
decisions grounded in available evidence.
NEJM Evidence is committed to advancing equity
and inclusion in medicine. Our editors, editorial
board, statistical reviewers, and publishers (https://
evidence​.­nejm​.­org/​­about/​­editors​-­and​-­publishers)
are committed to the principle that patients are
best served by work emanating from clinical tri-
als that reflect the patients for whom the diag-
nostics and therapeutics under study should be
used. To this end, NEJM Evidence will follow the
standard set by the Journal in that we will require
authors of all original research articles first pub-
lished in January 2022 or later to provide infor-
mation explicitly describing the diversity of the
patients enrolled and how that compares with
the target populations affected by the condition
under study. We are committed to the active
work required to dismantle structures responsi-
ble for the pervasive inequities that are incum-
bent on all of us to confront.
In the months and years to come, we will try
new approaches and adopt the most successful
ones as we seek to publish the work and com-
mentary that shapes clinical care today and in-
fluences research over the next generation. We in-
vite you to join us on this journey by submitting
your work to us (https://mc05​.­manuscriptcentral​
.­com/​­evidence) as we strive to advance the mis-
sion of NEJM Group: to serve health profession-
als around the world, so we can all do a better
job of serving patients.
Disclosure forms provided by the authors are available with
the full text of this editorial at NEJM.org.
This editorial was published on January 10, 2022, at NEJM.org.
DOI: 10.1056/NEJMe2118588
Copyright © 2022 Massachusetts Medical Society.

Covid-19 mRNA Vaccines — Six of One,

Half a Dozen of the Other
Eric J. Rubin, M.D., Ph.D., and Dan L. Longo, M.D.

In many countries, the availability of vaccines
has marked a turning point in the Covid-19 pan-
demic. Although the vaccines are imperfect,
breakthrough infections in fully vaccinated peo-
ple remain quite rare, even with recently emerg-
ing variants. Countries with high vaccination
rates have largely been able to reopen, and rates
of severe illness and death have dropped dra-
matically. But this has not been a smooth pro-
cess. Different vaccines have become available at
different times, and access to them has varied
markedly from country to country. Thus, the

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